Cleared Traditional

NICHOLS ADVANTAGE ALDOSTERONE ASSAY

K050784 · Nichols Institute Diagnostics · Chemistry
Jun 2005
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K050784 is an FDA 510(k) clearance for the NICHOLS ADVANTAGE ALDOSTERONE ASSAY, a Radioimmunoassay, Aldosterone (Class II — Special Controls, product code CJM), submitted by Nichols Institute Diagnostics (San Clemente, US). The FDA issued a Cleared decision on June 1, 2005, 65 days after receiving the submission on March 28, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1045.

Submission Details

510(k) Number K050784 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2005
Decision Date June 01, 2005
Days to Decision 65 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CJM — Radioimmunoassay, Aldosterone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1045

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